Intervention Characteristics/Basic Study Process:

G-CSF 230 mcg/m2 given days 4–17 unless the post-nadir neutrophil count exceeded 10x109/1 after day 12. Treatment repeated every 21 days for up to six cycles of chemotherapy (cyclophosphamide, doxorubicin, and etoposide).
Control was placebo injection.
Patients in the placebo group crossed over to G-CSF after episode of febrile neutropenia.

Sample Characteristics:

The study was comprised of 199 patients, of the 211 patients who had enrolled.
G-CSF = 95
Placebo = 101
Small-cell lung cancer

Setting:

Multicenter

Study Design:

Randomized, prospective, control phase III trial

Measurement Instruments/Methods:

Febrile neutropenia was the primary endpoint. Also looked at infectious complications and oral mucositis.
WHO scale
Oral candidiasis included as mucositis incidence, severity, and time to onset.
Duration of mucositis was determined by a combination of patient reporting and clinical examination findings.